Unspecified human immunodeficiency virus [HIV] disease MedDRA version: 7.0 Level: LLT Classification code 10020162
Conditions
Interventions
Product Name: L-000900612
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Tablet
Route of admin
Sponsors
Merck Sharp & Dohme Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patient is HIV positive as determined by a positive ELISA and has screening plasma HIV RNA (determined by the central laboratory) >5,000 copies/mL within 35 days prior to the treatment phase of this study. b. Patient has a screening CD4 cell count >50 cells/mm3 (determined by the central laboratory) within 35 days prior to the treatment phase of this study. c. Patient is ART experienced and on stable ART for >3 months. d. Patient has HIV with documented reduced susceptibility to at least one drug in each of the 3 classes of licensed oral ARTs (NNRTI + NRTI + PI) as per genotypic/phenotypic resistance report (PhenoSense GT) from the central laboratory. 005-10: Patients who completed the original open-label study (this includes patients who were in the open-label extension from double-blind and patients who entered the open-label post virologic failure treatment arm) through Week 96 will be eligible for continuing into this extension period of the study (the 14 day post therapy visit is not required prior to patients entering the extension). All patients must provide informed consent to participate in the extension. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Patient has used another experimental HIV-integrase inhibitor b. Patient requires use of NNRTI (Efavirenz, Nevirapine, Delavirdine) in OBT c. Patient has any condition or prestudy laboratory abnormality, or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: (1)Evaluate the antiretroviral activity of L 000900612 given b.i.d. at the studied doses compared to placebo, each in combination with OBT, as measured by the following parameters: (a)Proportions of patients with virologic response at Week 24; (b)Change from baseline in CD4 cell count at Week 24; (2)Evaluate the dose-response relationship for L 000900612 given b.i.d. in combination with OBT as measured by safety and efficacy parameters 005-10:To evaluate the long-term antiretroviral activity of raltegravir 400 mg b.i.d. in combination with OBT, as measured by (a)proportion of patients with HIV RNA levels below the threshold of quantification of AMPLICOR HIV-1 MonitorTM Ultrasensitive assay(<50 copies/mL; Version 1.5), (b)proportion of patients with HIV RNA levels below the threshold of quantification for AMPLICOR HIV-1 MonitorTM standard assay(<400 copies/mL), (c)change from baseline in plasma HIV RNA(log10 copies/mL), (d)change from baseline in CD4 cell count;Primary end point(s): Safety, tolerability, and HIV RNA changes at Week 24 005-10: Evaluate the safety and antiretroviral activity of Raltegravir in combination with an Optimized Background Therapy (OBT);Main Objective: In each of the two sub-studies, the primary objectives are: (1) Safety: Evaluate the safety and tolerability of L 000900612 given b.i.d. at the studied doses compared to placebo, each in combination with OBT for 24 weeks, assessed by clinical judgment based upon the accumulated safety data; (2) Efficacy: Evaluate the antiretroviral activity of L 000900612 given b.i.d. at the studied doses compared to placebo, each in combination with OBT for 24 weeks, as measured by change from baseline in plasma HIV RNA (log10 copies/mL) at Week 24 005-10: To evaluate the long-term safety and tolerability of raltegravir 400 mg b.i.d. in combination with OBT. | — |
Countries
Denmark, Germany, Italy, Spain, United Kingdom
Outcome results
None listed